CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Deep Neuromuscular Blockade (NMB) +4 moredrug
Likely dose
Sugammadex 4 mg/Kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03210376
NCT03210376Phase 4Completed

The Effect of Deep Neuromuscular Blockade With Sugammadex Reversal on Shoulder Pain of Elderly Patients Undergoing Robotic Surgery: A Single-Center Double-Blinded Randomized Controlled Trial

M.D. Anderson Cancer Center·interventional·Posted Jul 6, 2017·Updated Nov 25, 2020

In Brief

A Phase 4 clinical trial evaluating Deep Neuromuscular Blockade (NMB), Moderate Neuromuscular Blockade (NMB), and 3 other interventions for Malignant Neoplasms of Digestive Organs and 3 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Insufflation pressure (IP) is the creation of a pressure barrier of air/gas within the abdomen to allow the surgeon more space to work during abdominal surgery. Shoulder pain is a common complaint from patients who have had abdominal surgery and the pain is thought to be related to the use of IP. In addition to anesthesia (which keeps you asleep during surgery), the current standard practice is to block the nerve-muscle junction with a type of drug called neuromuscular blockade (NMB) which paralyzes the abdominal muscles. This means that a lower level of insufflation pressure is needed by the surgeon. To reverse the effects of NMB after surgery, a drug called neostigmine is given. The goal of this clinical research study is to compare the use of standard-of-care moderate NMB and neostigmine to the use of deep NMB and a drug called Sugammadex when given to elderly patients (patients who are 65 years of age or older) who are scheduled to have robotic abdominal surgery. "Deep" and "moderate" in this study refers to the dose or strength of the NMB given. This is an investigational study. Sugammadex and neostigmine are FDA approved and commercially available for the reversal of NMB. It is considered investigational to compare Sugammadex and neostigmine to learn if the use of one or the other in elderly patients can reduce the level of shoulder pain after surgery. Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.

Study Details

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJul 6, 2017
Enrollment StartNov 17, 2017
Primary CompletionSep 30, 2018
Study CompletionOct 22, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.0 years ago

Interventions

Deep Neuromuscular Blockade (NMB)drug

Deep Neuromuscular Blockade (NMB) given during surgery.

Moderate Neuromuscular Blockade (NMB)drug

Moderate Neuromuscular Blockade (NMB) given during surgery.

Sugammadexdrug

4 mg/Kg, intravenously as a single bolus injection after surgery.

Neostigminedrug

70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute after surgery.

Pain Assessmentbehavioral

Pain assessment done at about 15, 45, and 90 minutes after surgery.